Initial dose: 100 mg orally once a day. This dosage may be divided into two daily doses, and increased as tolerated every two to three days to a maximum recommended total daily dose of 400 mg. It is recommended that the dosage be titrated to decrease sodium retention, hypertension, weakness, hypokalemia, and any other signs or symptoms of primary hyperaldosteronism in this patient.
If this patient has an adrenal adenoma or carcinoma, the lowest possible Aldactone dosage should be given while waiting for surgery. Adrenal hyperplasia, however, usually does not respond to surgery, and chronic spironolactone therapy is recommended.
Patients with adrenal hyperplasia often require other antihypertensive therapy to control their associated hypertension.
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The effect of ATGAM when administered in conjunction with standard therapy at the time of diagnosis of the first rejection episode was studied under two different protocols with cadaveric and living related renal transplant patients. The results from these studies demonstrate the efficacy associated with the addition of ATGAM to standard therapy for treatment of the first rejection episode in renal allograft recipients. In Study 1, a randomized controlled, two center trial of ATGAM use for treatment of acute rejection in cadaveric renal transplant patients, the addition of ATGAM to standard rejection therapy (methylprednisolone sodium succinate) resulted in an increased frequency of resolution of the first acute rejection episode which was statistically significant (p < ). ATGAM-treated patients achieved a rejection resolution rate of 80% (36/45) compared with 54% (25/46) in the control group. There was a statistically significant improvement in functional graft survival favoring the ATGAM group (p < ), and a statistically significant steroid sparing effect during the first rejection episode among patients in the ATGAM group. There was no difference in the patient survival rate between the two treatment groups. Study 2 was a randomized controlled trial conducted at five different transplant centers. In this study, the addition of ATGAM to standard rejection therapy (bolus doses of Solu-Medrol® for treatment of acute rejection in recipients of living related renal transplants resulted in an increased frequency of rejection resolution and improvement in functional graft survival. Due to the small sample size, the difference between the ATGAM group and the control group in functional graft survival rate did not achieve statistical significance. Marginal statistical significance was demonstrated in rejection reversal rate and intravenous steroid sparing among ATGAM patients (p= and p=). Patient survival rates were similar in the two treatment groups.